Quality Systems

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.

Articles

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

Si Myra Tyson is a senior technical service associate for the Life Sciences Division of STERIS.

Paul Lopolito is a technical services specialist at STERIS, Mentor, OH.

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and 
provides a general cleaning recommendation based on laboratory and field testing.


Considerations for Cleaning Lipid Nanoparticles 

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

Productive Client-CDMO Relationships

Chris Spivey is the editorial director of 

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

Ensuring CGMP Standards for Data Integrity

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA Publishes Draft Guidance on Quality Assessments

Feliza Mirasol is the science editor for 

Editor of Pharmaceutical Technology Europe

Videos

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

Drug Digest: Emerging Therapies in All Shapes and Sizes

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Assessing the Success of CRISPR Gene Therapies Using ddPCR

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

A Robust Quality Culture Benefits All

Renato Rjavec is director of product management at Amplexor Life Sciences.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

Quality Assurance/Quality Control